Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Lactating Women on Select DOI Clinical Trial

Official title:

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511118
• Other study ID #: Pro00088919
• Secondary ID: HHSN275201000003
• Status: Recruiting
• Start date: October 4, 2018
• Est. completion date: September 23, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Emily Forgey
• Phone: 919-660-8720
• Email: emily.forgey[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Description:

The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: September 23, 2024
• Est. primary completion date: September 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lactating women who are receiving at least one DOI per SOC who are =180 days postpartum, and their infants (=180 days of age) who receive maternal breastmilk.
• Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Exclusion Criteria:

• Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
• Known pregnancy during PK sampling.

Related Conditions & MeSH terms

• Breastfed Infants of Mothers on Select DOI
• Lactating Women on Select DOI

Intervention

Drug:
• Tranexamic acid (TXA)
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• labetalol
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• metformin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• nifedipine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• clindamycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• oxycodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• azithromycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• escitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• sertraline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• ondansetron
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Ciprofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Doxycycline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Levofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Methylphenidate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Sumatriptan
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Citalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Cyclobenzaprine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Furosemide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Gabapentin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydrochlorothiazide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydroxyurea
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Rosuvastatin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Topiramate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Trazodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Valganciclovir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Venlafaxine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Verapamil
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Remdesivir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Anakinra
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Tocilizumab
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Fluvoxamine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Amoxicillin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Bupropion
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Duloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydrocodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Levetiracetam
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Paroxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Buprenorphine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montréal	Quebec
United States	University of New Mexico, Health Sciences Center	Albuquerque	New Mexico
United States	Texas Tech University Health Sciences Center School of Medicine.	Amarillo	Texas
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Duke University Maternal and Fetal Medicine	Durham	North Carolina
United States	University of Texas Medical Branch - Galveston	Galveston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California-San Diego Medical Center	La Jolla	California
United States	Loma Linda University Health	Loma Linda	California
United States	Children's Hospital and Clinics - Minneapolis	Minneapolis	Minnesota
United States	Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine	Philadelphia	Pennsylvania
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center	San Antonio	Texas
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M/P ratio	Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.	Until the infant becomes 180 days of age
Primary	DID	Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.	Until the infant becomes 180 days of age
Primary	RID	Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.	Until the infant becomes 180 days of age
Primary	I/M ratio	Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.	Until the infant becomes 180 days of age
Secondary	Safety profile of commonly used drugs in infants exposed to drugs in breastmilk	see Cohort 1-31 for listing of drugs	Until the infant becomes 180 days of age
Secondary	AE	Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.	Up until 180 days of age
Secondary	SAE	Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.	Up until 180 days of age
Secondary	ESI	Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure. ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age = 180 days	Until the infant becomes 180 days of age